An Open Case Series About Technical Feasibility of Routine Intraoperative Cholangiography (IOC) During Elective Rigid-hybrid Transvaginal Natural Orifice Transluminal Endoscopic Cholecystectomy (tvNCC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of patients with successful introduction of cholangiography catheter into cystic duct (yes/no)
研究概览
简要总结
While gold standard in the treatment of symptomatic gall stones is laparoscopic cholecystectomy with instruments introduced through multiple abdominal wall incisions, transvaginal access to the peritoneal cavity offers an alternative avoiding injury of the abdominal wall. Transvaginal hybrid-NOTES cholecystectomy has been demonstrated effective and safe. However it has not been demonstrated up-to-date if intraoperative cholangiography is feasible during such procedure. This observational case series describes success and technical feasibility of intraoperative cholangiography during transvaginal cholecystectomy. The investigators hypothesis is that cholangiography is feasible equal to conventional laparoscopic cholecystectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •symptomatic gallstone disease
- •age > 18 years
- •written informed consent
排除标准
- •age < 18 years
- •not able to understand informed consent
- •pregnancy
- •vaginal atresia
- •florid vaginal infection
- •gynecological neoplasia
- •allergy to Iod
- •missing informed consents
- •emergency procedure
结局指标
主要结局
Number of patients with successful introduction of cholangiography catheter into cystic duct (yes/no)
时间窗: intraoperative
Was the introduction of the cholangiography catheter into the cystic duct successfull during transvaginal rigid-hybrid cholecystectomy.
次要结局
- Time required for cholangiography(intraoperative)
- Intraoperative complications(intraoperative)
- postoperative complications(within 6 weeks from surgery)
研究者
Daniel Steinemann, MD
Principle Investigator
Cantonal Hosptal, Baselland
